The business of manufacturing medical devices is undergoing a data evolution. Business leaders need to understand how mastery of their data is essential to achieve leadership in a highly competitive market.
The pertinence and prevalence of the digital supply chain is growing. Manufacturers are building new processes that interconnect the back office with the front office and even directly to the customer’s operations. The industry is becoming more digitally enabled and data intensive.
Building a digital supply chain requires harvesting the raw materials that constitute it: Data.
3 challenges within the medical device manufacturing industry where data transparency can help:
Your ability to confidently act upon key business data facts – such as product or customer data – across the enterprise requires data transparency. You achieve data transparency by implementing business-led processes that govern the ability to collect, enrich and share well-defined, accurate, coherent and up-to-date information across the enterprise and beyond.
It’s difficult to make sure that your product information is transparent despite the clear business advantages that data transparency brings. Silos of organizations, applications and technologies all manage their own version of the truth. As a result, product information is fragmented. Furthermore, there is often no clear organization accountable for its construction, accuracy, coherence and provenance.
Learn more about how Stibo Systems’ Product Master Data Management as an advanced PIM solution delivers enhanced product data transparency
Having access to clear and complete product information plays an important part in the prevention of adverse events linked to information mishandling. In the event of device malfunctions, regulators require that their agencies be informed via centralized reporting systems in electronic format to ensure prompt and appropriate response.
A PIM solution can help by: Providing centralized, business-led controls on the completeness, accuracy and availability of the product information used for adverse event management.
Medical device manufacturers are looking for new ways to engage with their customers that create differentiated and valued services from portfolios of existing products. For example, they might bundle products together in packages more suitable to be consumed for certain types of medical procedures or care environments. Product-as-a-Service (PaaS), and value-based contracting are models that have the advantage of being differentiated services that are created from existing, value-based products. PaaS, for example, can deliver remote patient care or be part of an automated inventory management.
A PIM solution can help by: Defining, configuring and packaging the products and services that describe solution-centric packages and new delivery models.
As the healthcare industry continues to make advances in the patient care and safety, the codes for industry ethics strive for greater business transparency. Regulatory information management (RIM) systems need harmonized and coherent product information in order to establish the basis for reporting, for example, using STED (Summary Technical Documentation (STED), an international standard of medical device regulatory submissions).
Declarations to local and regional authorities require that information abides by specific organizational rules and structures. These need to be established in a unified way to ensure coherence and completeness. The Sunshine Act and EFPIA code are examples of how spending reporting, more commonly associated with the pharmaceutical industry, is also entering the medical device market. Analytics for spending requires not only good HCO/HCP information (healthcare organizations and professionals), but also reliable product information.
A PIM solution can help by: Providing business-led controls on the product data that feeds compliance functions, thus avoiding costs and penalties associated with data errors.
Manufacturers are adopting global standardization efforts such as MDR/IVDR to improve product traceability and patient safety. The Unique Device Identification (UDI) system uses standardized identification formats represented by RFID or barcodes, so that the manufacturer, location and use of medical devices can be accurately tracked.
A PIM solution can help by: Ensuring that product and packaging descriptions conform to standards for identification, safety and traceability.
Aligning on normalized product coding can facilitate the ordering process for your customers. Healthcare organizations (HCOs) and group purchasing organizations (GPOs) are implementing automated e-procurement processes in order to reduce cost and increase efficiency. Key to success is having normalized product data, often obtained from data pools, in order to eliminate ordering errors. Some HCOs are making it mandatory for their suppliers to use GS1. Some buying organizations impose penalties for incorrect information that delays their procurement operations.
A PIM solution can help by: Synchronizing accurate product information with GS1-certified data pools and customer e-procurement portals.
Learning management systems (LMS) need in-depth and accurate product reference data, in order to provide the most up-to-date information in the best format possible to better serve both internal employees, distributors, customers and patients.
A PIM solution can help by: Organizing and making available the product information — identification, description, packaging, regional variations, imagery, digital assets, MSDS, etc.
Being able to take confident and immediate action on the data you receive can change business outcome. With transparent product data, you can gain more insight into your business, such as understanding which products perform best via which sales channels. Insightful information allows you to anticipate rather than react to demand.
A PIM solution can help by: Organizing products into categories and hierarchies that support better analytics for business insight.
Normalizing product descriptions across the organization and into the customer’s hands can help support the journey to automate more internal processes and digitizing operations. Supplier catalog on-boarding, raw materials management, e-procurement, e-sales, remote inventory management and replenishment, fulfillment and many other processes are targets for joined up automation enabled with a unified and accurate PIM process. Having a highly granular level of product information enables companies to drill into product lines and understand how and where specific medical devices were manufactured, and which third parties supplied components and services.
A PIM solution can help by: Providing product information of medical devices in the format and context needed for consumption by all systems and applications within the supply chain.